Tissue treatment apparatus with functional mechanical stimulation and methods for reducing pain during tissue treatments

ABSTRACT

Apparatus and methods for delivering electromagnetic energy to a patient&#39;s tissue with a reduction in the pain experienced by the patient. The tissue treatment apparatus includes a delivery device configured to transfer electromagnetic energy through the skin surface to a region of tissue and a vibration device mechanically coupled with the delivery device. The vibration device is configured to transfer mechanical vibrations through the skin surface to the region of tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This Application is a continuation of application Ser. No. 12/649,781,filed Dec. 30, 2009, which claims the benefit of Application No.61/143,957, filed Jan. 12, 2009 and claims the benefit of ApplicationNo. 61/226,140, filed Jul. 16, 2009, each of which is herebyincorporated by reference herein in its entirety.

BACKGROUND

The invention generally relates to apparatus and methods for treatingtissue with high frequency energy and, more particularly, relates totreatment apparatus and methods for reducing patient pain withfunctional mechanical stimulation while treating tissue with highfrequency energy.

Various cosmetic tissue treatments use energy delivery devices tonon-invasively and non-ablatively treat tissue in order to improve apatient's appearance, such as smoothing and tightening skin; contouringalong the jaw line and under the chin, and improving skin texture;softening wrinkles around the mouth, eyes and forehead; reducingcellulite; or removing skin spots or hair. These non-invasive,transcutaneous procedures involve no surgery or injections but insteadproject electromagnetic energy into the tissue. Such non-invasive energydelivery devices may emit the electromagnetic energy in differentregions of the electromagnetic spectrum to accomplish the tissuetreatment with reduced patient recovery time in comparison with ablativeprocedures.

Skin is a type of body tissue that includes plural distinct layers. Theepidermis constitutes the visible outer layer on the surface. Thedermis, which underlies the epidermis, contains collagen fibers, bloodvessels, hair follicles, and other skin components. The hypodermis orsubcutaneous fat layer, which underlies the dermis, consists of fattissue and a web of collagen fibers in the form of fibrous septaerunning through the fat. The fibrous septae secure the dermis to theunderlying bone and muscle. Collagen fibers are recognized to be a veryflexible and stretchable protein and are characterized by a high tensilestrength.

The occurrence of wrinkles is an unavoidable natural process. Wrinklesare primarily associated with advancing age and skin damage arising fromexposure to damaging environmental factors. Environmental factorsinclude sun damage from exposure to sunlight, air pollution, smoking,repetitive facial movements such as frowning, and the natural effects ofgravity, which cause sagging of the skin with advancing aging.Deteriorating collagen exhibits a loss of elasticity, which results inthe formation of rhytids or wrinkling of the epidermis.

Electromagnetic radiation, specifically light and heat, applied to thedifferent layers of the skin can have a physiological effect on theskin's appearance. In particular, electromagnetic energy can arrest theformation of wrinkles and impart a more youthful skin appearance. Highfrequency treatment devices, such as radio-frequency (RF)-basedtreatment devices, may be used to treat skin tissue non-ablatively andnon-invasively with heat. Such high frequency devices operate bytransmitting high frequency energy through the epidermis to theunderlying tissue, while actively cooling the epidermis to preventthermal damage to a depth of the skin tissue near the skin surface. Thehigh frequency energy heats the tissue at depths beneath the cooledregion to a therapeutic temperature sufficient to denature the collagen,which causes the collagen fibers in the dermis to shrink and contract.In addition to the tightening of the treated tissue as the collagenfibers contract, treatment with high frequency energy also causes a mildinflammation. The inflammatory response of the treated tissue may causenew collagen to be generated over time, which can result in additionaltissue contraction. When the inflammatory response of the treated tissueis highly significant, the new collagen formed is known as scarcollagen.

Conventional high frequency treatment devices employ a handpiece, adisposable treatment tip coupled with a nose of the handpiece, and ahigh frequency generator connected by conductors inside the handpiecewith an electrode in the treatment tip. Conventional electrodes consistof a pattern of one or more metallic features carried on a flexibleelectrically insulating substrate, such as a thin film of polyimide. Thesubstrate contacts the patient's skin surface during treatment and themetallic features reside on the non-contact side of the substrate. Thetemperature of the treatment tip, which is measured by temperaturesensors carried on the treatment tip, is correlated with the temperatureof the patient's skin. During the procedure, the doctor controls theenergy density of the high frequency power delivered from the electrodewith a treatment setting. Treatment tips are frequently intended forsingle patient use and, therefore, are not reusable. Following thepatient treatment, the doctor or treatment technician removes thetreatment tip from the handpiece and, if disposable, discards it.

Patient pain is inherent in tissue treatments using electromagneticenergy. Patient pain is typically regulated to optimize the treatmentresult while also minimizing patient discomfort to make the proceduretolerable. A patient may be given an oral pain medication and/or a localtopical anesthesia cream may be applied as a numbing agent. At theinception of the treatment procedure, the doctor will initiallyadminister the high frequency energy at a treatment setting to one ormore test sites and monitor patient feedback on the heat sensationassociated with the treatment setting being used. A tolerable, yetcomfortable, treatment setting for the treatment procedure isestablished based upon the patient feedback from the test sites.

The treatment electrode used in the treatment includes a conductorregion delimited by an outer peripheral edge. For monopolar energydelivery, an edge effect has been observed at the outer peripheral edgethat causes the energy density of the high frequency energy delivered tothe tissue to be non-uniform across the surface area of the treatmentelectrode. Specifically, the energy density is highest near theperipheral edge of the electrode. As a result, tissue proximate to theouter peripheral edge of the electrode is heated to a higher temperaturethan tissue proximate to the interior surface area of the electrode. Thehigher temperatures near the peripheral edge form hot spot thermal zonesthat are a highly likely source of heat-related pain perceived by thepatient. Because patient discomfort is linked with the treatmentsetting, reducing the treatment level to counteract the edge effecteffectively reduces the average energy density for the high frequencyenergy delivered during the treatment procedure.

In general, the results and the chance for pain or discomfort scale withthe treatment setting used by the doctor. What is needed, therefore, areapparatus and methods for reducing the pain associated with such tissuetreatments so that patient discomfort is alleviated and therapeuticresults can be improved by increasing the treatment setting.

SUMMARY

The embodiments of the invention are generally directed to apparatus andmethods for transcutaneously delivering electromagnetic energy to treattissue underlying a skin surface, particularly during non-invasive andnon-ablative therapeutic tissue treatments, with reduced patient pain.

In one embodiment, a tissue treatment apparatus is provided for use intreating a region of tissue located beneath a skin surface withelectromagnetic energy. The tissue treatment apparatus includes adelivery device configured to transfer the electromagnetic energythrough the skin surface to the region of tissue and a vibration devicemechanically coupled with the delivery device. The vibration device isconfigured to transfer mechanical vibrations through the skin surface tothe region of tissue. The mechanical vibrations reduce patientdiscomfort (i.e., pain) associated with treatment and, in particular,treatment with electromagnetic energy that heats the targeted tissue.

In another embodiment, a method is provided for operating a tissuetreatment apparatus to treat a region of tissue located beneath a skinsurface with electromagnetic energy. The method includes delivering theelectromagnetic energy through the skin surface to the region of tissueand transferring mechanical vibrations through the skin surface and intothe region of tissue. The mechanical vibrations reduce patientdiscomfort (i.e., pain) associated with treatment and, in particular,treatment with electromagnetic energy that heats the targeted tissue.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a diagrammatic view of a treatment system with a handpiece, atreatment tip, a console, and a generator in accordance with anembodiment of the invention.

FIG. 2 is a perspective view of an assembly consisting of an embodimentof the handpiece and treatment tip for use with the treatment system ofFIG. 1.

FIG. 3 is an exploded view of the assembly of FIG. 2.

FIG. 4 is a top view of the assembly of FIG. 2 with the cover of thehandpiece removed to expose the interior of the handpiece and avibration device in accordance with an embodiment of the invention.

FIG. 5 is a side cross-sectional view of the handpiece taken generallyalong line 5-5 in FIG. 2.

FIGS. 6-8 are side cross-sectional views similar to FIG. 5 illustratingthe operation of the treatment system to use the vibration device tomove the treatment tip relative to the skin surface of the patient.

FIG. 9 is a detailed view of the treatment tip and a forward end of thehandpiece in use during a treatment procedure conducted using thetreatment system of FIGS. 1-8.

FIG. 10 is an exploded view of a handpiece and treatment tip assemblythat includes a vibration device in accordance with an alternativeembodiment of the invention.

FIG. 11 is a top view of the assembled handpiece and treatment tip ofFIG. 10 with the cover of the handpiece removed to expose the interiorof the handpiece and the vibration device.

FIGS. 12 and 13 are side cross-sectional views illustrating theoperation of the treatment system in which the vibration device of FIG.11 is moving the treatment tip relative to the skin surface of thepatient.

FIG. 14 is a cross-sectional view taken generally along line 14-14 inFIG. 12.

FIG. 15 is a detailed view similar to FIG. 9 of the treatment tip in useduring a treatment procedure conducted using the treatment system ofFIGS. 1 and 10-14.

FIG. 16 is a perspective view of an assembly consisting of anotheralternative embodiment of the handpiece and treatment tip for use withthe treatment system of FIG. 1.

FIG. 17 is an exploded view of the assembly of FIG. 16.

FIG. 18 is a cross-sectional view of the handpiece taken generally alongline 18-18 in FIG. 16.

FIG. 18A is an enlarged view of a portion of FIG. 18.

FIGS. 19 and 20 are cross-sectional views similar to FIG. 18illustrating the operation of the treatment system to use the vibrationdevice to move the treatment tip relative to the skin surface of thepatient.

FIG. 19A is an enlarged view of a portion of FIG. 19.

FIGS. 21 and 22 are detailed views similar to FIGS. 9 and 15 of thetreatment tip in use during a treatment procedure conducted using thetreatment system of FIGS. 1 and 16-20.

FIG. 23 is a diagrammatic view illustrating a stepped-amplitude protocolfor vibration to provide functional mechanical stimulation whendelivering high frequency energy from the treatment electrode to thepatient's tissue.

FIG. 24 is a diagrammatic view illustrating a ramped protocol forvibration to provide functional mechanical stimulation when deliveringhigh frequency energy from the treatment electrode to the patient'stissue.

DETAILED DESCRIPTION

With reference to FIGS. 1-3, a treatment apparatus 10 generally includesa handpiece 12, a treatment tip 14 coupled in a removable and releasablemanner with the handpiece 12, a console generally indicated by referencenumeral 16, and a system controller 18. The system controller 18, whichis incorporated into the console 16, orchestrates the global operationof the different individual components of the treatment apparatus 10.Under the control of the system controller 18 and any operatorinteraction with the system controller 18 at the console 16 and withcontrols at the handpiece 12, the treatment apparatus 10 is adapted tonon-invasively and non-ablatively deliver electromagnetic energy in ahigh frequency band of the electromagnetic spectrum to a region of apatient's tissue 32 (FIG. 9). The delivered electromagnetic energy heatsthe tissue 32 to a targeted temperature range. The elevation intemperature will produce for example, changes in collagen fibers thatachieve a desired treatment result, such as removing or reducingwrinkles and otherwise tightening the skin to thereby improve theappearance of a patient 20 receiving the treatment.

The treatment tip 14 carries an electromagnetic energy delivery memberin the representative form of an active treatment electrode 24. In arepresentative embodiment, the treatment electrode 24 may include anelectrically-insulating substrate 30 composed of a non-conductivedielectric material and a region 28 of an electrical conductor carriedon the electrically-insulating substrate 30. The conductor region 28 ofthe treatment electrode 24 is physically carried on a non-contact sideof the substrate 30 and is therefore separated by the substrate 30 froma skin surface 34 (FIG. 9). In one embodiment, the substrate 30 of thetreatment electrode 24 may comprise a thin flexible base polymer filmcarrying the conductor region 28 and thin conductive (e.g., copper)traces or leads on the substrate 30 that electrically couple theconductor region 28 with contact pads inside the treatment tip 14. Thebase polymer film of substrate 30 may be, for example, polyimide oranother material with a relatively high electrical resistivity and arelatively high thermal conductivity. The conductive leads may containcopper or another material characterized by a relatively high electricalconductivity. Instead of the representative single conductor region 28,the conductor region 28 of treatment electrode 24 may be segmented intoplural individual electrodes that can be individually powered tosequentially deliver electromagnetic energy to the tissue 32.

The conductor region 28 of the treatment electrode 24 is electricallycoupled by a set of insulated and shielded conductors 22 that extendexteriorly of the handpiece 12 to the generator 26 at the console 16.The generator 26 is configured to generate the electromagnetic energyused in the treatment to impart a therapeutic effect by heating targettissue 32 beneath the patient's skin surface 34. The generator 26, whichhas the form of a high frequency power supply, is equipped with anelectrical circuit operative to generate high frequency electricalcurrent, typically in the radio-frequency (RF) band of theelectromagnetic spectrum. The operating frequency of generator 26 may bein the range of several hundred kHz to about twenty (20) MHz. In oneembodiment, the generator 26 is a 400 watt, 6.78 MHz high frequencygenerator. The electrical circuit in the generator 26 converts a linealternating current voltage into drive signals for the treatmentelectrode 24. The drive signals have an energy content and a duty cycleappropriate for the amount of power and the mode of operation that havebeen selected by the clinician, as understood by a person havingordinary skill in the art. In alternative embodiments, the treatmentapparatus 10 may be configured to deliver energy in the infrared band,microwave band, or another high frequency band of the electromagneticspectrum, rather than within the RF band, to the patient's tissue 32.

The system controller 18 may represent practically any computer,computer system, or programmable device recognized by a person havingordinary skill in the art and capable of carrying out the functionsdescribed herein, as will be understood by those of ordinary skill inthe art. System controller 18 typically includes at least one processor23 coupled to a memory 25. Processor 23 may represent one or moreprocessors (e.g., microprocessors), and memory 25 may represent therandom access memory (RAM) devices comprising the main storage of systemcontroller 18, as well as any supplemental levels of memory, e.g., cachememories, non-volatile or backup memories (e.g. programmable or flashmemories), read-only memories, etc. In addition, memory 25 may beconsidered to include memory storage physically located elsewhere insystem controller 18, e.g., any cache memory in a processor 23, as wellas any storage capacity used as a virtual memory, e.g., as stored on amass storage device 27 or another computer (not shown) coupled to systemcontroller 18 via a network.

System controller 18 also typically receives a number of inputs andoutputs for communicating information externally. For interface with auser or operator, system controller 18 typically includes one or moreuser input devices (e.g., a keyboard, a mouse, a trackball, a joystick,a touchpad, a keypad, a stylus, and/or a microphone, among others) inthe form of a user interface 29. The user interface 29 may be used todeliver instructions to the system controller 18 to adjust the generator26 and to establish an arbitrary treatment setting based upon operatorinput at the handpiece 12. System controller 18 may also include adisplay 31 (e.g., a CRT monitor or an LCD display panel, among others).

System controller 18 operates under the control of an operating system33, and executes or otherwise relies upon various computer softwareapplications, components, programs, objects, modules, data structures,etc. In general, the routines executed by the system controller 18 tooperate the treatment system 10, whether implemented as part of anoperating system or a specific application, component, program, object,module or sequence of instructions will be referred to herein as“computer program code”. The computer program code typically comprisesone or more instructions that are resident at various times in variousmemory and storage devices in a computer, and that, when read andexecuted by one or more processors in a computer, causes that computerto perform the steps necessary to execute steps or elements embodyingthe various aspects of the invention.

The system controller 18 includes digital and/or analog circuitry thatinterfaces the processor 23 with the generator 26 for regulating thepower delivered from the generator 26 to the treatment electrode 20.Generator software 35 resides as an application in the memory 25 and isexecuted by the processor 23 in order to issue commands that control theoperation of the generator 26. The system controller 18 includes digitaland/or analog circuitry that interfaces the processor 23 with a cryogensupply 65, such as a pre-filled canister containing pressurized cryogen,and a control valve 79 (FIG. 17) for regulating the cryogen delivered tothe treatment electrode 20. Cryogen software 37 resides as anapplication in the memory 25 and is executed by the processor 23 inorder to issue commands that control the operation of the cryogen supply65 and the control valve 79.

During a non-ablative and non-invasive tissue treatment, a portion 130(FIG. 9) of the treatment electrode 24 has a directly contactingrelationship with the skin surface 34 of the patient 20. In therepresentative arrangement, the substrate 30 is arranged between theconductor region 28 and the skin surface 34 so that a portion of thesubstrate 30 directly contacts the skin surface 34. Electromagneticenergy is transmitted in a transcutaneous manner from the conductorregion 28 through the thickness of substrate 30 and across the surfacearea of the portion 130 to the tissue 32 by capacitively coupling withthe tissue 32 of the patient 20.

The treatment tip 14 includes temperature sensors (not shown), such asthermistors or thermocouples, that are constructed to detect thetemperature of the treatment electrode 24 and/or treatment tip 14. Themeasured temperature reflects the temperature of the treated tissue 32and may be used as feedback in a control loop controlling energydelivery and/or cooling of the skin surface. The handpiece 12 ortreatment tip 14 may also include pressure sensors (not shown) fordetecting physical contact between the treatment electrode 24 and theskin surface 34 of the patient 20.

An activation button 36, which is accessible to the operator from theexterior of the handpiece 12, is configured to be actuated to close aswitch in a normally open circuit with the generator 26. The closedcircuit energizes the treatment electrode 24. Actuation of theactivation button 36 triggers delivery of the high frequency energy overa short timed delivery cycle to the target tissue 32. After a fixedamount of time has elapsed, the delivery of high frequency energy fromthe treatment electrode 24 to the tissue 32 at the treatment site isdiscontinued. The handpiece 12 is manipulated to position the treatmenttip 14 near a different treatment site on the skin surface 34 andanother cycle of high frequency energy is delivered to the patient'stissue 32. This process is repeated for an arbitrary number of treatmentsites.

High frequency electrical current flowing between the treatmentelectrode 24 and the patient 20 is concentrated at the skin surface 34and the underlying tissue 32 across the contacting surface area of theportion 130 of the treatment electrode 24. Capacitive coupling of thehigh frequency electromagnetic energy relies on energy transfer from theconductor region 28 through the dielectric material of the substrate 30to create an electric field across the surface area where the treatmentelectrode 24 contacts the patient's body. The time-varying electricfield induces electrical currents within the surrounding tissue 32beneath the skin surface 34.

Because of the natural resistance of tissue 32 to electrical currentflow, volumetric heating results within the tissue 32. The volumetricheating delivers a therapeutic effect to the tissue 32 near thetreatment site. For example, heating to a temperature of 50° C. or 60°C. or higher will contract collagen, which will result in tissuetightening or another aesthetic effect to improve the patient'sappearance. The heating depth in the tissue 32 is based upon the sizeand geometry of the treatment electrode 24 and, contingent upon theselection and configuration of the treatment tip 14, can be controlledto extend from a few hundred microns beneath the skin surface 34 toseveral millimeters.

A non-therapeutic passive return electrode 38 is used to electricallycouple the patient 20 with the generator 26. During patient treatment,the high frequency current flows from the treatment electrode 24 throughthe treated tissue 32 and the intervening bulk of the patient 20 to thereturn electrode 38 and then to the generator 26 through conductorsinside a return cable 40 to define a closed circuit or current path 42.The return electrode 38 is physically attached by, for example, anadhesive bond to a site on the body surface of the patient 20, such asthe patient's back.

The surface area of the return electrode 38 in contact with the patient20 is relatively large in comparison with the surface area of thetreatment electrode 24. Consequently, at the tissue adjacent to thereturn electrode 38, the current density flowing from the patient 20 tothe return electrode 38 is relatively low in comparison with the currentdensity flowing from the treatment electrode 24 to the patient 20.Because negligible heating is produced at its attachment site to thepatient, a non-therapeutic effect is created in the tissue adjacent tothe return electrode 38.

Although the treatment electrode 24 and the return electrode 38 arerepresentatively configured for the delivery of monopolar high frequencyenergy, the treatment electrode 24 may be configured to deliver bipolarhigh frequency energy. The modifications to the treatment apparatus 10required to deliver bipolar high frequency energy are familiar to aperson having ordinary skill in the art. For example, the returnelectrode 56 may be eliminated from the treatment apparatus 10 and abipolar type of treatment electrode substituted for the monopolartreatment electrode 24.

With reference to FIGS. 2-5, the handpiece 12 is constructed from ahousing 46 that includes a body 48, a cover 50 assembled by conventionalfasteners with the body 48, and an electrical/fluid interface 52 for thetreatment tip 14. The housing 46 may be fabricated by an injectionmolding process using a suitable polymer resin as a constructionmaterial. The body 48 and cover 50 constitute shell halves that areintegrally fastened together as an assembly. The housing 46 encloses aninterior cavity 54 bounded on one side by an interior surface of thebody 48 and bounded on the other side by an interior surface of thecover 50. After the body 48 and cover 50 are assembled, the handpiece 12has a smoothly contoured shape suitable for gripping and manipulation byan operator. The operator maneuvers the treatment tip 14 and treatmentelectrode 24 to a location proximate to the skin surface 34 and,typically, to place the treatment electrode 24 in a contactingrelationship with the skin surface 34.

The housing 46 includes a nose 56 and a window 58 in the nose 56 that issized for the insertion and removal of the treatment tip 14. Theelectrical/fluid interface 52 is disposed between the window 58 and theinterior cavity 54 enclosed inside the housing 46. The treatment tip 14is sized to be inserted through the window 58 and configured to bephysically engaged with the handpiece 12, as described below. In theengaged state, the contact pads carried on the substrate 30 of thetreatment electrode 24 establish respective electrical contacts withcomplementary electrical contacts 60 (FIG. 4), such as pogo pins,carried by the electrical/fluid interface 52 of the handpiece 12. Theseelectrical contacts 60 are electrically coupled with one or more of theconductors 22 that extend from the handpiece 12 to the generator 26 andsystem controller 18. A portion of the treatment electrode 24 projectingoutwardly from the nose 56 includes the portion 130 of the substrate 30overlying the conductor region 28 so that the treatment electrode 24 isat least partially exposed through the window 58.

The handpiece 12 includes a control panel 62 and a display 64 that arecarried by the cover 50. The control panel 62 may include variouscontrols, such as controls 69, 70 used to respectively increase andreduce the treatment setting and controls 71, 72 that respectivelyenable and disable the controls 69, 70. The display 64 may be used todisplay information including, but not limited to, energy delivered,tissue impedance, duration, and feedback on procedure technique. Theavailability of the information displayed on the display 64 mayconveniently eliminate the need to display identical information at theconsole 16 or may duplicate information displayed at the console 16. Bydisplaying information at the handpiece 12, the operator can focus onthe procedure without diverting his attention to glance at informationdisplayed by the display on the console 16. In one embodiment, thedisplay 64 may constitute a thin, flat liquid crystal display (LCD)comprised of a light source or reflector and an arbitrary number ofcolor or monochrome pixels arrayed in front of the light source orreflector. A driver circuit (not shown) is provided to control theoperation of the display 64.

The treatment tip 14 includes a rigid outer shell 66 and openings 68defined on diametrically opposite sides of the outer shell 66. Theopenings 68 are used to temporarily secure the treatment tip 14 with thehandpiece 12 in advance of a patient treatment procedure. The handpiece12 is configured with a control valve 79 (FIG. 17) used to deliver acryogen spray to the treatment electrode 24 for controlling thetemperature of the treatment electrode 24. A conduit 63 extends throughthe interior cavity 54 inside the housing 46 and through a strain relief61 held in an opening of the housing 46 of handpiece 12. The conduit 63connects the control valve 79 with a cryogen supply 65, such as apre-filled canister containing pressurized cryogen, stored at theconsole 16.

One purpose of the cryogen spray is to pre-cool the patient's epidermis,before powering the treatment electrode 24, by heat transfer between thetreatment electrode 24 and the skin surface 34. The cooling creates areverse thermal gradient in the tissue 32 such that the temperature ofthe tissue 32 at and near the skin surface 34 is cooler than thetemperature of the tissue 32 deeper within the epidermis or dermis. As aresult, the high frequency energy delivered to the tissue 32 fails toheat all or a portion of the patient's epidermis to a temperaturesufficient to cause significant epidermal thermal damage. Depths oftissue 32 that are not significantly cooled by pre-cooling will warm upto therapeutic temperatures, which cause a desired therapeutic effect.The amount and/or duration of pre-cooling may be used to select theprotected depth of untreated tissue 32. The cryogen delivered by thecontrol valve 79 (FIG. 17) may also be used to cool portions of thetissue 32 during and/or after heating by the high frequency energytransferred from the treatment electrode 24. Post-cooling may prevent orreduce heat delivered deeper into the tissue 32 from conducting upwardand heating shallower tissue regions, such as the epidermis, totemperatures which could thermally damage shallower tissue regions eventhough external energy delivery to the targeted tissue 32 has ceased.

Various duty cycles of cooling and heating that rely on cooling and highfrequency energy transfer from the treatment electrode 24 are utilizedcontingent upon the type of treatment and the desired type oftherapeutic effect. The cooling and heating duty cycles may becontrolled and coordinated by operation of the controller 18. Suitablecryogens include low boiling point fluids, but are not limited to, R134a(1,1,1,2-Tetrafluoroethane) refrigerant, liquid nitrogen, and R152arefrigerant (1,1-Difluoroethane). Heat can be extracted from thetreatment electrode 24 by virtue of evaporative cooling of the lowboiling point fluid, which cools the treatment electrode 24. Inalternative embodiments, the patient's skin and/or the treatmentelectrode 24 may be cooled in a different manner, such as with athermoelectric or Peltier device, closed-loop fluid cooling, or a Zimmercooler that is configured to deliver a forced stream of cold air ontothe skin surface 34.

With reference to FIGS. 3-5, the handpiece 12 of the treatment apparatus10 incorporates a vibrator or vibration device, generally indicated byreference numeral 76. The vibration device 76 is configured to oscillateor vibrate the treatment tip 14 and treatment electrode 24 at arelatively low frequency relative to the headpiece 12 and the skinsurface 34. In particular, the vibration device 76 causes the portion ofthe substrate 30 of the treatment electrode 24 in direct contact withthe skin surface 34 to oscillate or vibrate laterally within a plane 74that is substantially parallel to the skin surface 34. The plane 74reflects the planar nature of the portion of the skin surface 34 thatcontacts the treatment electrode 24 during a treatment procedure.

The vibration device 76 includes a carriage 78 located within theinterior cavity 54 of housing 46. The carriage 78 supports theelectrical/fluid interface 52 that is coupled with the treatment tip 14.The carriage 78 is comprised of a first carriage member 80 and a secondcarriage member 82 rigidly joined with the first carriage member 80 todefine an integral structure. In an alternative embodiment, the carriage78 may be a unitary structure that combines the first and secondcarriage members 80, 82 to form a construction consisting of a singlepiece of material.

Spring arms 84 are located on opposite sides of the carriage 78 and eachof the spring arms 84 includes an outwardly-projecting tab 85. When thetreatment tip 14 is mounted to the handpiece 12, the spring arms 84deflect inwardly when contacted by a portion of the outer shell 66 ofthe treatment tip 14. As the inward motion of the treatment tip 14toward the electrical/fluid interface 52 continues, each of the tabs 85eventually become registered with one of the openings 68. Thisregistration permits the spring arms 84 to resiliently cantileveroutwardly so that the tabs 85 engage the openings 68. The treatment tip14 is released for removal from the handpiece 12 by manually applyinginward pressure through access ports 87 in the housing 46 to buttons 89on the spring tabs 84. The inward pressure disengages the tabs 85 fromthe openings 68, which releases the engagement between the handpiece 12and treatment tip 14 and permits the treatment tip 14 to be separatedfrom the handpiece 12. After separation from the handpiece 12, thetreatment tip 14 may be discarded or may be retained for a futuretreatment procedure.

Projecting outwardly from one side of the carriage 78 are arms 86, 88and projecting outwardly from an opposite side of the carriage 78 arearms 90, 92. One of a plurality of vibration dampers 94, 96, 98, 100 isattached to the free end of each of the arms 86, 88, 90, 92. Thevibration dampers 94, 96, 98, 100 are received in recesses 102, 104,106, 108 partially defined in the body 48 of the housing 46 of thehandpiece 12 and partially defined in the cover 50 of the housing 46.When the body 48 and cover 50 are assembled together, the vibrationdampers 94, 96, 98, 100 are captured within the recesses 102, 104, 106,108 to supply a mechanical connection between the housing 46 and thevibration device 76 and operate to suspend the carriage 78 relative tothe housing 46 of the handpiece 12. The vibration dampers 94, 96, 98,100 are formed from a relatively soft durometer elastomeric material,such as a silicone rubber, which contributes to the vibration isolationof the housing 46.

The carriage 78 includes an electric motor 112 and a cavity 110 that isshaped to receive the electric motor 112. For example, the cavity 110and the outer casing of the electric motor 112 may each have thegeometrical shape of a right circular cylinder. A fastener (not shown)may be used to physically connect the electric motor 144 with thecarriage 78.

An off-center or eccentric counterweight 114 is attached to one end ofan output shaft 116 of the electric motor 112. The counterweight 114 isspun by the electric motor 112 about an axis of rotation 118 that isgenerally collinear with the output shaft 116. The counterweight 114 hasa center of mass 115 that is offset or spaced apart from the axis ofrotation 118 of the output shaft 116. As a result, the center of mass115 of the counterweight 114 and the axis of rotation 118 of the outputshaft 116 are not collinear. When the electric motor 112 is energizedand operating to spin the counterweight 114, the off-balance motion ofthe mass of the counterweight 114 induces a vibration in the electricmotor 112, which is transferred from the electric motor 112 to thecarriage 78 and, ultimately, from the carriage 78 to the treatment tip14 and treatment electrode 24.

The vibration amplitude, A, and the vibration frequency may be adjustedto achieve a targeted reduction in the pain perceived by the patient 20.The vibration amplitude, A, represents the maximum displacement of theportion 130 of the treatment electrode 24 in contact with the skinsurface 34 relative to a normal or neutral position (FIG. 5). Thevibration amplitude, A, determines the range of transverse or lateralmotion for the portion 130 of the treatment electrode 24 in contact withthe skin surface 34 relative to the neutral position and, thereby, thesurface area on the skin surface 34 effectively contacted by thesubstrate 30 of the treatment electrode 14 during each completeoscillation between the positive and negative amplitudes. For example,increasing the amplitude, A, increases the effective surface area on theskin surface 34 contacted by the treatment electrode 24 and will averagethe energy density transferred to the tissue 32 across the effectivesurface area so that the hot spot thermal zones near the peripheral edgeof the treatment electrode 24 are reduced. The vibration frequency isdetermined from the time to complete a fully full cycle for thevibration, such as measured from positive amplitude to the next positiveamplitude or measured from the negative amplitude to the subsequentnegative amplitude. The lateral or transverse motion of the portion 130of the treatment electrode 24 in contact with the skin surface 34 isdefined as a direction transverse to a surface normal 125 to the skinsurface 34.

The treatment tip 14 may include a tip frame as described in U.S.Application No. 61/143,537, filed Jan. 9, 2009, and U.S. Application No.61/226,138, filed Jul. 16, 2009, each entitled “Tissue TreatmentApparatus and Systems with Pain Mitigation and Methods for MitigatingPain During Tissue Treatments”, which are hereby incorporated byreference herein in their entirety. The tip frame may contact the skinsurface 34 and space a peripheral portion of the treatment electrode 24from the skin surface 34. A portion of the rigid outer shell 66 of thetreatment tip 14 encircling the treatment electrode 24 may also be in acontacting relationship the skin surface 34. In each instance, thevibration may be transferred at least in part by a structural contactother than the portion 130 of the treatment electrode 24.

In one embodiment, the electric motor 112 may be a direct current (DC)motor that is controlled by a DC drive voltage supplied from a powersupply (not shown) at the system controller 18 through at least one ofthe insulated and shielded conductors 22. The DC drive voltage energizesthe motor windings and rotates the output shaft 116 and counterweight114, preferably at a constant angular velocity, about the axis ofrotation 118. The portion 130 of the treatment electrode 24 in contactwith the skin surface 34 will cyclically move from the positivevibration amplitude to the negative vibration amplitude and then fromthe negative vibration amplitude to the positive vibration amplitude asthe counterweight 114 rotates. The vibration amplitude, A, increases inmagnitude proportionate to the magnitude of DC drive voltage used tocontrol the electric motor 112. The strength of the vibrations is alsodirectly linked to the vibration frequency, which is proportional to theangular velocity of the counterweight 114 about the axis of rotation118. Increasing the angular velocity of the counterweight 114 byoperating the electric motor 112 at a higher speed (higher frequency ofmotion) also operates to increase the vibration magnitude.

In an alternative embodiment, the DC drive voltage may control theelectric motor 112 to bidirectionally rotate the counterweight 114 andoutput shaft 116 about the axis of rotation 118. The direction ofrotation of the counterweight 114 about the axis of rotation 118 isalternated with an appropriate drive waveform for the DC drive voltage.The counterweight 114 travels through only a portion of a fullrevolution of the output shaft 116 before the counterweight 114 changesdirection and moves in the opposite direction. This causes a vibrationin the electric motor 112 and in the carriage 78 coupled to the electricmotor 112 as the counterweight 114 is rapidly moved back and forth in acyclic rocking motion relative to the axis of rotation 118.

The vibration amplitude, A, of the treatment tip 14 can also beincreased or decreased, respectively, by increasing or decreasing themass and/or geometrical shape of the counterweight 114. Because of thenature of the non-rigid mechanical connections, the vibration dampers94, 96, 98, 100 operate to effectively enhance or amplify the vibrationamplitude of the carriage 78. The vibration amplitude, A, can be alsocontrolled by changing properties, such as size and durometer, of thevibration dampers 94, 96, 98, 100. The greatest magnitude for thevibration amplitude, A, may be output near a resonance frequency of thevibration device 76, which is determined by the mass of thecounterweight 114 and by the compliance of the vibration dampers 94, 96,98, 100.

In the representative embodiment, the counterweight 114 has acylindrical shape. However, many different types and geometrical shapesof counterweight 114 can be used. For example, the counterweight 114 maybe wedge- or pie-shaped eccentric with one end of the eccentric coupledto the output shaft 116 so that the majority of the mass extends to oneside of the output shaft 116. The offset between the center of mass 115of the counterweight 114 and the axis of rotation of the output shaft116 can be adjusted in different device embodiments to provide strongeror weaker vibrations, as desired to achieve a particular pain managementeffect.

In various embodiments, the lateral vibration amplitude, A, may be onthe order of several millimeters, typically 5 millimeters or less, andthe vibration frequency may be on the order of 5 Hz to 1 kHz, preferablybetween in a range of 20 Hz to 100 Hz. The window 58 of the handpiece 12is preferably dimensioned in relation to extent of the vibrationamplitude, A, such that the outer shell 66 of the treatment tip 14 doesnot contact the housing 46 of the handpiece 14 when vibrated. Theclearance ensures that the handpiece 14 does not interfere with thevibration of the treatment tip 14.

Because the mechanical connections between the carriage 78 and housing46 of the handpiece 12 are not rigid, the vibration dampers 94, 96, 98,100 operate to dampen the resonance between the carriage 78 and thehousing 46 of the handpiece 12. In particular, this non-rigid mechanicalconnection reduces the vibration perceived by an operator grasping thehousing 46 of the handpiece 12.

With reference to FIGS. 5-9, the use of the vibration device 76 isillustrated. The counterweight 114 is continuously spun by the electricmotor 112, when electric motor 112 is energized, about the axis ofrotation 118 in a direction generally indicated by the single-headedarrow 120. During one half of a complete revolution, the center of mass115 of the counterweight 114 is located above the axis of rotation 118.While the center of mass 115 and the axis of rotation 118 have thisspatial relationship, the carriage 78 and treatment tip 14 move in adirection indicated by the single-headed arrow 122 in FIG. 6 from theneutral position shown in FIG. 5. The resulting motion of the portion130 of treatment electrode 24 contacting skin surface 34 is generallywithin the plane 74.

Immediately after the positive vibration amplitude is reached, as shownin FIG. 7, the treatment tip 14 and carriage 78 will reverse directionand move the treatment electrode 24 generally in a direction withinplane 74 indicated by the single-headed arrow 124 in FIG. 7. During thishalf of a complete revolution of the counterweight 114, the center ofmass 115 of the counterweight 114 is located below the axis of rotation118. When the negative vibration amplitude is reached, as shown in FIG.8, the treatment tip 14 and carriage 78 will reverse direction and againmove the treatment electrode 24 generally in direction 122 within plane74 toward the neutral position shown in FIG. 5 and eventually to theposition of positive vibration amplitude in FIG. 7.

The motion of the treatment tip 14 and carriage 78 moves the portion 130of the treatment electrode 24 in contact with the skin surface 34transversely or laterally within plane 74 relative to the skin surface34 and relative to the handpiece 12, as best shown in FIG. 9. In FIG. 9,the portion 130 of the treatment electrode 24 is shown as movingrelative to the skin surface 34 through the positive amplitude, A, overone-half of its full range of motion. During the vibration,electromagnetic energy is transferred from the conductor region 28through the portion 130 of the substrate 30 to the tissue 32. Theoscillating or vibrational nature of the transverse motion laterallyrelative to the skin surface 34, which is indicated generally by thedouble headed arrow 126, operates to reduce the pain experienced by thepatient during the treatment procedure. Contact between the portion 130of the treatment electrode 24 and the skin surface 34 tends to slightlydeform the tissue, as apparent in FIG. 9.

With reference to FIGS. 10-15 and in accordance with an alternativeembodiment of the invention, a vibrator in the representative form of avibration device 140 includes a carriage 142, an electric motor 144, aoutput shaft 146 coupled with the electric motor 144, and a cam element148 mounted to one end of the output shaft 146. The output shaft 146 isrotated by the electric motor 144 about an axis of rotation 150generally collinear with the output shaft 146. The carriage 142, whichis located within the interior cavity 54 of housing 46, supports theelectrical/fluid interface 52. The carriage 142 is comprised of a firstcarriage member 136 and a second carriage member 138 rigidly joined byconventional fasteners with the first carriage member 136 to define anintegral structure. In an alternative embodiment, the carriage 142 mayhave a unitary construction that combines the first and second carriagemembers 136, 138 into a single piece of material.

The body 48 of the handpiece 12 includes a chamber 145 that is shaped tohold the electric motor 144. In one embodiment, the electric motor 144may be a direct current (DC) motor that is energized by power suppliedfrom the system controller 18 through at least one of the insulated andshielded conductors 22. A fastener (not shown) may be used to physicallyconnect the electric motor 144 with the body 48 of the handpiece 12.

The cam element 148, which is rigidly affixed to the end of the outputshaft 146, has a peripheral surface that is characterized by aneccentric shape with a circular section 149 and a non-circular section151 that contact a curved cam surface 154 defined in the carriage 142.The non-circular section 151 features an off-center apex 152 that isoffset laterally from the axis of rotation 150 of the output shaft 146.The shape of the cam element 148 is representatively pear shaped orteardrop shaped, although the embodiments of the invention are not solimited as the sections 149, 151, which are best shown in FIG. 14, maydiffer from the representative embodiment.

The cam element 148 translates circular or rotary motion of the outputshaft 146 driven about the axis of rotation 150 by the electric motor144, when energized, into oscillating or rocking motion of the carriage142. Vibration or oscillation of the carriage 142 causes the treatmenttip 14 and, in particular, the portion 130 of the treatment electrode 24in contact with the skin surface 34 to likewise vibrate in the plane 74and relative to the skin surface 34. Specifically, the cam element 148produces a smooth reciprocating motion of the carriage 142 back andforth as the sections 149, 151 periodically ride in a track along thecurved cam surface 154 defined in the carriage 142. In a representativeembodiment, the cam surface 154 is a section of an arcuate surface, suchas a cylinder, and, preferably, is approximately one-half of a rightcylindrical section that provides a drive surface for the cam followerrepresented by the cam element 148. The vibration amplitude, A, of thetreatment tip 14 can be increased or decreased by, for example,increasing or decreasing the profile of the cam element 148 so that thedistance between the apex 152 and axis of rotation 150 is altered. Thevibration frequency is increased or decreased by increasing ordecreasing, respectively, the speed of the electric motor 144.

The carriage 142 is mechanically connected with the housing 46 by abushing 156 and a shaft 158 received inside a bore extending centrallythrough the bushing 156. The bushing 156, which extends transverselyacross the width of the interior cavity 54, has opposite ends capturedwithin bores defined in a spaced-apart pair of mounting flanges 155, 157and a central portion that is captured within an opening in a mountingflange 159 integrally formed with the carriage 142. The mounting flanges155, 157 are integrally formed with the body 48 and are spaced apart bya distance sufficient to prevent contact between the body 48 and thecarriage 142. The openings in the mounting flanges 155, 157 are alignedwith the opening in the mounting flange 159, and the mounting flanges155, 157 are disposed on opposite sides of mounting flange 159 in theassembly. When the carriage 142 is connected with the housing 46, thecarriage 142 is positioned between the electric motor 144 in chamber 145and the electrical/fluid interface 52.

The shaft 158 has an enlarged head 160 at one end that is larger thanthe inner diameter of the bore in bushing 156 and an opposite end thatprojects from the bushing 156. The former end of the shaft 158 issecured with a fastener 162, such as a C-clip, that blocks anysubstantial transverse movement of the shaft 158 relative to the bore ofthe bushing 156 and the mounting flange 159. The enlarged head 160 andfastener 162 capture the shaft 158 and bushing 156 with the mountingflanges 155, 157 and limit the extent of lateral movement of the shaft158 and bushing 156, as well as the extent of the lateral motion of thecarriage 142. The shaft 158 freely rotates about a fixed pivot axis 164generally aligned with the coincident centerlines of the shaft 158 andthe bore of bushing 156, and generally aligned transverse to the axis ofrotation 150 of the output shaft 146. The amplitude for the motion ofthe portion 130 of treatment electrode 24 is also related to thedistance from the pivot axis 164. The carriage 142 is restrained againstany linear movement relative to the housing 46.

A biasing element, which has the representative form of a compressionspring 166, applies a continuous downward force on the carriage 142. Thecompression spring 166 is captured in a compressed state between a boss168 on the carriage 142 and another boss 169 on the cover 50 of thehousing 46. The bosses 168, 169 are sized to receive and secure theopposite ends of the compression spring 166. Alternatively, a differenttype of biasing element other than a compression spring 166 may be usedto apply the continuous downward biasing force to the carriage 142. Thecontinuous downward force applied by the compression spring 166 to thecarriage 142 ensures that the cam surface 154 remains in constantcontact with the sections 149, 151 of the cam element 148 and preventswobbling or jittering of the carriage 142.

With reference to FIGS. 12-15, the operation of the vibration device 140may be illustrated. When energized, the electric motor 144 rotates theoutput shaft 146 and the cam element 148 in a direction indicated by thesingle-headed arrow 170 and preferably at a constant angular velocity.For purposes of description, the carriage 142 may initially be in theposition as shown in FIG. 12 at which the non-circular section 151 ofthe cam element 148 has a contacting relationship with the curved camsurface 154 of the carriage 142. As best shown in FIG. 14, the camelement 148 has an angular orientation in which the apex 152 contactsthe cam surface 154 to provide the positive amplitude (maximum positivedisplacement) shown in FIG. 12.

As the output shaft 146 is rotated by the electric motor 144, thenon-circular section 151 of the cam element 148 remains in contact withthe curved cam surface 154 of the carriage 142. Although the expansionof the compression spring 166 is constrained by the contact between thecam surface 154 and the non-circular section 151 of the cam element 148,the coils of the compression spring 166 progressively expand as the camelement 148 rotates. The contact between the non-circular section 151and the curved cam surface 154 and the progressive expansion of thecompression spring 166 causes the carriage 142 to rotate about the pivotaxis 164 in a direction indicated by the single headed arrow 172 (FIG.12). The treatment tip 14 and the portion 130 of the treatment electrode24 move from the position of positive vibration amplitude shown in FIG.12 toward a neutral position. As rotation continues, the non-circularsection 151 of the cam element 148 maintains the contacting relationshipwith the curved cam surface 154 over approximately one-quarter of acomplete revolution of the cam element 148.

Eventually, the cam element 148 assumes an angular orientation in whichthe non-circular section 151 has a non-contacting relationship with thecurved cam surface 154 on the carriage 142, which represents a neutralposition. The compression spring 166 continues to forcibly extend,unrestrained by the contact between the apex 152 and cam surface 154,and applies a spring force that urges the carriage 142 to continue torotate about the pivot axis 164 in the direction 172, as shown in FIG.12, toward the position of positive vibration amplitude for the portion130 of the treatment electrode 24 shown in FIG. 13. The cam element 148continues to rotate through angular orientations representingapproximately one-half of a complete revolution. Eventually, the camsurface 154 and the circular section 149 of the cam element 148 contactto halt the motion in the direction 172 with the portion 130 at thelocation of negative amplitude (maximum negative displacement), as shownin FIG. 13.

With advancing rotation, the non-circular section 151 of the cam element148 again contacts the curved cam surface 154 on the carriage 142. Thiscontacting relationship initiates movement of the carriage 142,treatment tip 12, and portion 130 of the treatment electrode 24 in adirection indicated by the single headed arrow 171 (FIG. 13). Thenon-circular section 151 of the cam element 148 maintains the contactingrelationship with the curved cam surface 154 over approximatelyone-quarter of a complete revolution of the cam element 148, which movesthe portion 130 of the treatment electrode 24 through the neutralposition and toward the position with positive amplitude. The apex 152ultimately reaches the angular orientation shown in FIG. 14 and theportion 130 of the treatment electrode 24 is again at the location ofpositive amplitude shown in FIG. 12. The cycle then repeats at theprescribed frequency of vibration. Thus, rotation of the cam element 148causes the carriage 142, the treatment tip 14, and the portion 130 ofthe treatment electrode 24 to cyclically move approximately laterally ortransversely relative to the skin surface 34.

In use to perform a treatment procedure, the physician selects a type oftreatment tip 14 based on the procedure to be performed and the size ofthe surface area on the patient 20 to be treated, as well as the depthof cooling and heating desired for the treatment procedure. Theprocedure protocol may include a combination of pulse count, pulseduration, energy level, and heating profile. After choosing thetreatment tip 14 and attaching it to the handpiece 12, the physicianmarks the intended treatment area on the patient 20 with a grid ofremovable markings that are easily wiped away post-procedure. Eachdiscrete square in the grid corresponds approximately to the size of theportion 130 of the treatment electrode 24 that is placed in directcontact with the skin surface 34. The markings operate as a placementguide on the patient's skin surface 34 for the treatment procedure. Thereturn electrode 38 is attached to the patient 20 to supply the currentpath 42 for the high frequency current back to the generator 26.

After the optional application of a conductive fluid, each square withinthe grid is sequentially treated with high frequency energy deliveredfrom the treatment electrode 24. Specifically, at each grid square, thephysician lands the portion 130 of treatment electrode 24 directlyagainst the patient's skin and actuates the activation button 36 on thehandpiece 12. The handpiece 12 processes information from the treatmenttip 14 about skin temperature and contact, treatment force or pressureagainst the skin, cooling system function, and other types of relevantdata. This information is sent from the handpiece 12 to the console 16in order to generate the proper high frequency signal at the generator26.

The control valve 79 (FIG. 17) regulates the delivery of cryogen, whichcools and protects the skin's superficial layers proximate to the skinsurface 34. The cryogen is used to pre-cool the patient's epidermis,before powering the treatment electrode 24, by extracting heat from thewarmer skin. The treatment electrode 24 transmits high frequency energyto the skin while serving as a contact cooling membrane for the cryogen.The controller 18 monitors a combination of inputs, such astemperatures, power levels and delivery duration, to precisely andsafely control the high frequency energy and cooling delivery to eachtreatment site in the grid. Cooling the epidermis limits the temperatureto lessen the likelihood of thermal damage to the epidermis. Depths oftissue 32 that are not significantly cooled by pre-cooling will beheated to therapeutic temperatures resulting in the desired therapeuticeffect. The amount or duration of pre-cooling may be used to select theprotected depth of untreated tissue 32.

The cryogen may also be used to cool the contacted tissue 32 during,before, and/or after heating by the transferred high frequencyelectromagnetic energy. Various duty cycles of cooling and heating byhigh frequency energy transfer are utilized depending on the type oftreatment and the desired type of therapeutic effect. The cooling andheating duty cycles may be controlled and coordinated by operation ofthe system controller 18.

After energy delivery is completed, the handpiece 12 is maneuvered tolift the portion 130 of the treatment electrode 24 from the skin surface34. The handpiece 12 and treatment tip 14 are moved among subsequenttreatment locations in the grid and energy is delivered is a similarmanner for treating large regions on the patient 20, such as thepatient's face. Multiple passes over the entire grid of the treatmentzone, separated in time by a quiescent period of few minutes, may beused to enhance the treatment, as is understood by persons skilled inthe art. Multiple treatments, which are separated temporally by alengthier healing period, may be needed for a successful treatment thatsupplies the desired cosmetic effect.

The vibration devices 76, 140 are functional during the treatmentprocedure for vibrating the treatment tip 14 and, in particular, forvibrating the portion 130 of the treatment electrode 24 contacting theskin surface 34 and overlying the region of the tissue 32 being heatedby the high frequency energy. The vibration may be continuous or may betriggered to occur only when the activation button 36 is actuated. Forexample, the vibration devices 76, 140 may be activated for the sametime period over which energy delivery occurs or for a different timeperiod that is either shorter or longer. For example, the mechanicalvibrations may be initiated after the electromagnetic energy delivery isinitiated and persist through the remainder of the energy delivery, aswell as continue for a given time after energy delivery ceases. Thevibration devices 76, 140 may be activated to transfer mechanicalvibrations through the skin surface 34 to the tissue 32 before, during,and/or after the delivery of the electromagnetic energy at each gridlocation to cause heating in a corresponding region of the tissue 32.

The vibration of the treatment tip 14 using one of the vibration devices76, 140 may be effective to decrease the sensation of pain experiencedby the patient 20 from the delivery of electromagnetic energy during atreatment procedure. Specifically, in one aspect, the vibration isbelieved to operate to average the heat applied across the treatmentarea within each treatment site because the treatment tip 14 and, morespecifically, the portion 130 of treatment electrode 24 contacting theskin surface 34 is in continuous motion roughly within the boundaries ofthe grid area. In contrast, the treatment electrodes of conventionaltreatment tips are held pressed with a constant force of contact withthe skin surface 34 during the delivery of electromagnetic energy. Thedynamic motion of the portion 130 of treatment electrode 24 directlycontacting the skin surface 34 compensates for hot spot thermal zones ofnon-uniform higher temperatures, which are highly likely sources of heatpain.

Vibration of the portion 130 of the treatment electrode 24 may alsooperate to interfere with the ability of nerves in the treated tissue 32to send heat-related pain signals to the brain of the patient 20.Although not wishing to be limited by theory, it is believed under thegate control theory of pain that the perception of physical pain is nota direct result of activation of nociceptors (sensory neurons or nerveendings that sends signals that cause the perception of pain in responseto a potentially damaging stimulus). Instead, the perception of physicalpain is modulated by interaction between neurons that transmit pain andneurons that do not transmit pain. The gate control theory of painteaches that activation of nerves that do not transmit pain signals,such as nerves sensitive to pressure and vibration delivered by thevibration devices 76, 140, can interfere with signals from nociceptorsand thereby inhibit a patient's perception of pain, such as pain arisingfrom heating of the tissue.

The train of vibrations delivered by the vibration devices 76, 140induces repetitive back and forth movement of the tissue 32 in thetreatment area that may act to increase local blood perfusion.Increasing the local blood perfusion may in turn act to increase thetemperature loading capabilities of the skin and assist in removingheat.

The treatment depth may be adjusted by, for example, programmingdifferent output parameters (i.e., high frequency currents and voltages,duration over which current is applied, etc.) for the high frequencypower supplied from generator 26 to the treatment electrode 24. Coolingcan be adjusted by providing a pre-treatment cooling period, aconcurrent-treatment cooling period, a post-treatment cooling period, asdesired, and also by controlling the temperature of the treatment tip 14during the cooling to be, for example, either extremely cold, mediumcooled, or mildly cooled, as desired. The treatment depth may also becontingent upon other variables, such as the specific type of tissue 32involved in the treatment.

With reference to FIGS. 16-18 and 18A and in accordance with analternative embodiment of the invention, a handpiece 200 is constructedfrom a housing 202 that includes a body 204, a cover 206 assembled byconventional fasteners 208 with the body 204, and an electrical/fluidinterface 210 configured to be coupled with a complementaryelectrical/fluid interface of the treatment tip 14. The body 204 andcover 206 of the housing 202 may be fabricated by an injection moldingprocess using a suitable polymer resin as a construction material. Thebody 204 and cover 206 constitute shell halves that are integrallyfastened together by the fasteners 208 as an assembly.

The housing 202 encloses an interior cavity 212 bounded on one side byan interior surface of the body 204 and bounded on the other side by aninterior surface of the cover 206 that confronts the interior surface ofbody 204. After the body 204 and cover 206 are assembled, the handpiece200 has a smoothly contoured shape suitable for gripping andmanipulation by an operator. When the handpiece 200 is gripped, theoperator can maneuver the treatment tip 14 and treatment electrode 24 toa location proximate to the skin surface 34 and, typically, to place thetreatment electrode 24 in a contacting relationship with the skinsurface 34 for executing a treatment repetition.

A forward nose 214 of the housing 202 includes a window 216 sized forthe insertion and removal of the treatment tip 14. The electrical/fluidinterface 210 is disposed between the window 216 and the majority of theinterior cavity 212 inside the housing 202. The treatment tip 14 issized to be inserted through the window 216 and configured to bephysically engaged with the handpiece 200, as described below. In theengaged state, the contact pads (not shown) on the substrate 30 of thetreatment electrode 24 establish respective electrical contacts withcomplementary electrical contacts 220, such as pogo pins, carried by theelectrical/fluid interface 210 of the handpiece 200. These electricalcontacts 220 are electrically coupled with one or more of the conductors22 that extend from the handpiece 200 to the generator 26 and the systemcontroller 18. A portion of the treatment electrode 24 projectingoutwardly from the nose 214 includes the portion of the substrate 30overlying the conductor region 28 so that, when the treatment tip 14 ismechanically engaged with the handpiece 200 and the fluid and electricalconnections are established, the treatment electrode 24 is exposedthrough the window 216.

A shallow recess 176 defined in the cover 206 of handpiece 12 has a rimthat is geometrically shaped to receive a control pad 178 with an outerperimeter of similar geometrical shape. The control pad 178 includes adisplay 180, controls 182, 184 that scroll different operationalfunctions of treatment apparatus 10 on the display 180, controls 186,188 used to respectively increase and decrease the setting for thefunction currently on the display 180, and a control 190 to engage asetting changed using controls 182, 184, 186, 188. The display 180 maybe used to display information including, but not limited to, energydelivered, tissue impedance, duration, and feedback on proceduretechnique. The availability of the information displayed on the display180 may conveniently eliminate the need to display identical informationat the console 16, or may duplicate information displayed at the console16. By displaying information at the handpiece 200, the operator canfocus on the procedure without diverting his attention to glance atinformation displayed at the console 16. In one embodiment, the display180 at the handpiece 200 may constitute a thin, flat liquid crystaldisplay (LCD) comprised of a light source or reflector and an arbitrarynumber of color or monochrome pixels arrayed in front of the lightsource or reflector. A driver circuit (not shown) is provided to controlthe operation of the display 180. A connector 174 extends through anopening in the cover 206 to provide communication between the controlpad 178 and system controller 18 through the insulated and shieldedconductors 22 (FIG. 1).

Various printed circuit boards 194, 195, 196, 197 are located inside theinterior cavity 212. Each of the printed circuit boards 194, 195, 196,197 carries electrical circuitry with electronic components that supportthe operation and functionality of the treatment apparatus 10.

The handpiece 200 includes a frame 230, a carriage 232 that is movablerelative to the frame 230, and a vibrator in the representative form ofa vibration device generally indicated by reference numeral 234.Spring-loaded buttons 192 a,b carried by the carriage 232 engageopenings 193 a,b in the treatment tip 14 to mechanically attach thetreatment tip 14 with the carriage 232 as an assembly. The treatment tip14 can be removed from the handpiece 12 by disengaging the spring-loadedbuttons 192 a,b from the openings 193 a,b and applying an axial forcedirected to remove the treatment tip 14 from the handpiece 12. A groovedguide 236 is fastened to the frame 230 and a guide rail 238 on theunderside of the carriage 232 has opposite side edges that are engagedwith the longitudinal recess in the grooved guide 236.

The vibration device 234 includes a powered actuator in therepresentative form of a solenoid 244 that is configured to move thecarriage 232 relative to the frame 230. The solenoid 244 has an outputshaft 240 that is mechanically connected with the carriage 232 through amechanical interface 242. The solenoid 244 is operated by drive signalsgenerated at the system controller 18 and communicated via one or moreof the insulated and shielded conductors 22. When the windings of thesolenoid 244 are energized, the solenoid 244 is powered to extend theoutput shaft 240. Extension of the output shaft 240 causes the carriage232 to move toward the window 216 and, accordingly, the carriage 232 tomove the treatment tip 14 relative to the handpiece 12 in an outwarddirection through the window 216.

The mechanical coupling between the guide rail 238 and the grooved guide236 constrains motion of the carriage 232 and the treatment tip 14 to beapproximately linear and normal to the plane of the window 216. However,a person having ordinary skill in the art will appreciate that thelinear movement of the mass represented by the carriage 232 and thetreatment tip 14 may depart from ideality and that minor x-y motion ofthe treatment electrode 24 within the plane of the window 216 and, thus,normal to the linear movement may be present. During use, a portion ofthe treatment tip 14, typically a portion of the treatment electrode 24and most typically a portion of the substrate 30 on the opposite side ofthe treatment electrode 24 from the conductor region 28, is placed incontact with the skin surface 34.

As best shown in FIG. 18A, the mechanical interface 242 includes a pairof resilient members 250, 252, which are tension springs in therepresentative embodiment, that are attached to the output shaft 240 byan attachment structure 254 and to the carriage 232 by anotherattachment structure 256. The resilient members 250, 252 bridge acrossthe gap between the end of the output shaft 240 and the carriage 232. Aforce sensor 258 is clipped to the carriage 232 and, therefore, rideswith the carriage 232 as the carriage 232 is moved. The force sensor 258supplies feedback on the vibration of carriage 232 and detects contactof the treatment tip 14 with the skin surface 34. A ram 260 of themechanical interface 242 is secured to the end of the output shaft 240of the solenoid 244. The ram 260 is disposed inside of a cylinder 262,which also encloses a cup-shaped receptacle 264 and a resilient member266 in the representative form of a compression spring. The resilientmember 266 is retained inside the cylinder 262 and is disposed betweenthe ram 260 and the receptacle 264. A portion of the receptacle 264contacts the force sensor 258 when the output shaft 240 is extended tomove the carriage 232 relative to the frame 230. The extension pushesthe carriage 232 toward the window 216 in a direction away from thestationary solenoid 244 and compresses the resilient member 266.

The force sensor 258 supplies feedback to the system controller 18 onthe variation in the contact force between the treatment tip 14 and theskin surface 34. For example, the force of contact between the treatmenttip 14 and the skin surface 34 may be less than one kilogram (e.g., 0.35kg) and, when the mechanical vibrations are initiated, the force ofcontact may change (±100%) as the carriage 232 and the treatment tip 14move axially relative to the skin surface 34.

When power is removed from the windings of the solenoid 244, theresilient members 250, 252 cooperate to supply a spring bias that shiftsthe carriage 232 in a direction away from the window 216. A first magnet267 is secured to the output shaft 240 of the solenoid 244 and a secondmagnet 268 is held by the frame 230. The first magnet 267 moves with theoutput shaft 240 relative to the second magnet 268, which remainsstationary. The resilient members 250, 252 are assisted in shifting thecarriage 232 by a magnetic force of attraction between the first andsecond magnets 267, 268. In one embodiment, the magnets 267, 268 arecomposed of a material, such as a ferromagnetic material, that ispermanently magnetized. The first and second magnets 267, 268 supply afunctional hard stop to the rearward motion of the output shaft 240.

The alternately back and forth movement of the carriage 232 may beimplemented in response to powering the treatment electrode 24 during atreatment procedure. The forced motion of the carriage 232 by operationof the solenoid 244 moves the treatment tip 14, which is mechanicallyconnected with the carriage 232 and moves as a unit with the carriage232, from an initial position, as best shown in FIG. 18, toward the skinsurface 34. The forward end of the treatment tip 14, which carriestreatment element 24, applies a force vector directed primarily inwardto the skin surface 34. When the output shaft 240 is fully extended, theforward motion of the treatment tip 14 and carriage 232 halts, as shownin FIGS. 19, 19A. This inwardly directed force depresses the skinsurface 34 over a shallow amplitude, A, as best shown in FIG. 21, thatrepresents the extension of the carriage 232 and the treatment tip 14.The tissue 32 applies a counterforce that resists the inwardly directedforce from the treatment tip 14 but that yields slightly to permit theskin surface 34 to be depressed.

When the solenoid 244 is de-energized, the force applied by the outputshaft 240 is removed from the carriage 232 and treatment tip 14. Anattractive force acting between the magnets 267, 268 causes the outputshaft 240 to initially lose contact with the carriage 232, as best shownin FIG. 19A. The output shaft 240 is induced to move to a fullyretracted position shown in FIG. 20. The resilient members 250, 252 areextended by this motion of the output shaft 240, which in turn applies areturn force to the carriage 232. The return force transferred from theresilient members 250, 252 to the carriage 232 causes the carriage 232to rapidly return the initial position of FIG. 18 and the resilientmembers 250, 252 to return to their initial position of FIGS. 18, 18A.This retracts the treatment tip 14 from the skin surface 34. Because theclinician is gripping the handpiece 12 and pressing the treatment tip 14toward the skin surface 34, contact is maintained between the treatmentelectrode 24 and the skin surface 34 as the treatment tip 14 is vibratedby the vibration device 234.

The rapid repetition of this movement sequence imparts a series ofmechanical vibrations to and through the skin surface 34 that propagateinto the underlying tissue 32 as mechanical vibration waves. In variousembodiments, the vibration frequency may be on the order of 20 Hz to 80Hz and the amplitude, A, may be on the order of 1 mm to 6 mm. Thealternation in the direction of motion of the carriage 232 gives rise toreciprocating movement of the treatment tip 14 and the portion of thetreatment tip 14 contacting the skin surface 34.

The solenoid 244 of the vibration device 234 is coupled by ring-shapedvibration dampers 270, 272 with a recessed groove defined in the frame230 and another recessed groove defined in an air flow deflector 274partially surrounding the exterior of the solenoid 244. The vibrationdampers 270, 272 may be composed of a relatively soft durometerelastomeric material like a silicone rubber. The vibration dampers 270,272 are axially spaced apart at different locations along the length ofthe solenoid 244. The vibration dampers 270, 272 supply a mechanicalconnection between the housing 202 and the solenoid 244 of the vibrationdevice 234, but operate to attenuate the transfer of vibration from thesolenoid 244.

The solenoid 244 is cooled by a forced air flow from a blower or fan276. The air flow from the fan 276 is directed about the exterior of thesolenoid 244 by the air flow deflector 274, which is separated fromoutside case of the solenoid 244 by a gap. The solenoid 244 generatesheat when powered. The force flow of air extracts heat from the solenoid244, which is cooled and, therefore, has a lower operating temperaturethan in the absence of active cooling. The housing 202 includesventilation openings (not shown) communicating with the interior cavity212 and that cooperate with the fan 276 to intake air at ambienttemperature and to exhaust air warmed in excess of ambient temperatureby the heat generated by solenoid 244.

An activation button 280, which is accessible to the operator from theexterior of the handpiece 12, is configured to be actuated to actuate aswitch 282 that closes a normally open circuit to connect the treatmentelectrode 24 with the generator 26. The closed circuit energizes thetreatment electrode 24 with power supplied to the handpiece 12 from thegenerator 26 and also electrically powers the solenoid 244 of thevibration device 234 to prompt the transfer of mechanical vibrations tothe skin surface 34. Consequently, actuation of the activation button280 triggers delivery of the high frequency energy and the delivery ofmechanical vibrations over a timed delivery cycle to the target tissue32.

The timing of the mechanical vibration delivery with respect to theelectromagnetic energy delivery is selected according to the specifictreatment procedure, and may be orchestrated under the control of thesystem controller 18 at the console 16. Various delivery profiles forthe electromagnetic energy and the mechanical vibrations may bedeveloped for different types of patient treatments. In one embodiment,the onset of mechanical vibrations is delayed in time until after theenergy delivery is initiated. In one embodiment, the mechanicalvibrations are continued for a given time after energy deliveryconcludes. In other embodiments, the onset and/or end of the mechanicalvibrations may coincide with the onset and end of energy delivery.

With reference to FIG. 23, an exemplary delivery profile for highfrequency power and vibration as a function of time to the tissue 32 isillustrated. The vibration profile may be used to operate vibrationdevice 234 (FIG. 16-22) or, alternatively, to operate either thevibration device 234 (FIG. 1-9) or the vibration device 234 (FIGS.10-15).

In the specific delivery profile, high frequency power is delivered in apulse initiating at a time of 0.0 seconds (the origin of the x-axis) andwith the treatment electrode 24 in a contacting relationship with theskin surface 34 to promote energy transfer, as well as the subsequentvibration transfer. The delivery of the high frequency power isindicated diagrammatically by line 300. Power delivery may be precededby a pulse of coolant to cool the tissue 32 inwardly from the skinsurface 34.

Mechanical vibrations are initiated subsequent to the initiation ofpower delivery, for example at a time of 0.2 seconds after the deliveryof electromagnetic power is initiated. While electromagnetic power isdelivered from the treatment electrode 24, the power of the mechanicalvibration is increased with increasing time. Over an interval of 0.35seconds (from 0.2 seconds to 0.55 seconds), the solenoid 244 isenergized at a first power level, as indicated by line 302, and heldconstant at the first power level to deliver mechanical vibrations witha first amplitude and/or frequency and in a direction primarilyperpendicular to the skin surface 34.

At a future time (e.g., 0.55 seconds after the initiation ofelectromagnetic power delivery), the power to the solenoid 244 isincreased to a second power level, as indicated by line 304, toestablish mechanical vibrations with a second amplitude and/or frequencygreater than the first amplitude and/or frequency. The power is heldconstant at the second power level 304 to deliver mechanical vibrationsat the second amplitude and/or frequency. Vibration at the secondamplitude and/or frequency of level 304 is sustained over an intervalof, for example, 0.35 seconds (from 0.55 seconds to 0.9 seconds).

At a more advanced time into the future (e.g., 0.9 seconds after theinitiation of electromagnetic power delivery), the power to the solenoid244 is again increased to a third power level, as indicated by line 306,to deliver mechanical vibrations with a third amplitude and/or frequencygreater than the second amplitude and/or frequency. The power is heldconstant at the third power level 306 to deliver mechanical vibrationsat the third amplitude and/or frequency. Vibration is sustained at thethird amplitude and/or frequency of the third power level 306 over aninterval of, for example, 0.63 seconds (from 0.9 seconds to 1.53seconds). The delivery of high frequency electromagnetic energy isdiscontinued (e.g., after a treatment time of 1.4 seconds) before themechanical vibrations are discontinued, as indicated by line 308, ashort time (e.g., a little over one millisecond) thereafter. As aresult, the mechanical vibrations continue after power delivery in thepulse of high frequency power 300 concludes.

Preferred vibration power for the mechanical vibrations is between 1watt and 30 watts, preferably between 2 watts and 20 watts, morepreferably between 2 watts and 12 watts, and most preferably between 3watts and 12 watts.

A person having ordinary skill in the art will appreciate that thevibration profile in FIG. 23 is merely exemplary and that the number ofdifferent vibration levels and the amplitude and duration of eachvibration level may differ from the exemplary vibration profile. Thevibration profile may be adjusted to provide functional mechanicalstimulation to accommodate varying nerve densities in different tissuetypes and different levels of patient skin laxity and thereby provide asuitable measure of pain relief to the patient.

With reference to FIG. 24 in which like reference numerals refer to likefeatures in FIG. 23 and in accordance with an alternative embodiment,another exemplary profile for high frequency power delivery andvibration delivery as a function of time to the tissue 32 isillustrated. The vibration profile may be used to operate vibrationdevice 234 (FIG. 16-22) or, alternatively, either the vibration device234 (FIG. 1-9) or the vibration device 234 (FIGS. 10-15). The ramping ofthe vibration level in the profile of FIG. 23 contrasts with the abruptchanges in vibration level exhibited in the profile of FIG. 22.

Mechanical vibrations are initiated after electromagnetic energydelivery is initiated, for example at a time of 0.2 seconds after thedelivery of electromagnetic power is initiated. While electromagneticpower is being delivered, the power of the mechanical vibration isincreased with increasing time. Specifically, the solenoid 244 isenergized at, for example, 0.2 seconds and the vibration power is rampedupwardly at a given rate over an interval spanning, for example, from0.2 seconds to 0.9 seconds, as indicated by line 310, to delivermechanical vibrations with increasing amplitude and/or frequency. In therepresentative embodiment, the vibration power is linearly ramped at aconstant rate to a maximum vibration power (e.g., 15.7 Watts), at whichpoint the maximum vibration power is sustained to provide anapproximately continuous delivery of mechanical vibrations during theremainder of the electromagnetic energy delivery, as indicated by line312. At a given time (e.g., 0.25 seconds), the delivery ofelectromagnetic energy is discontinued, and the power to the solenoid244 is switched off and the mechanical vibrations cease, as indicated byline 314. In the representative embodiment, the cessation of mechanicalvibration occurs after the delivery of electromagnetic energy isdiscontinued.

References herein to terms such as “vertical”, “horizontal”, etc. aremade by way of example, and not by way of limitation, to establish aframe of reference. It is understood that various other frames ofreference may be employed for describing the invention without departingfrom the spirit and scope of the invention. It is also understood thatfeatures of the invention are not necessarily shown to scale in thedrawings. Furthermore, to the extent that the terms “composed of”,“includes”, “having”, “has”, “with”, or variants thereof are used ineither the detailed description or the claims, such terms are intendedto be inclusive and open-ended in a manner similar to the term“comprising”.

It will be understood that when an element is described as being“attached”, “connected”, or “coupled” to another element, it can bedirectly connected or coupled to the other element or interveningelements may be present. In contrast, when an element is described asbeing “directly attached”, “directly connected”, or “directly coupled”to another element, there are no intervening elements present.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention. Asused herein, the singular forms “a”, “an” and “the” are intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. It will be further understood that the terms “comprises”and/or “comprising,” when used in this specification, specify thepresence of stated features, integers, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, integers, steps, operations, elements,components, and/or groups thereof.

While the invention has been illustrated by a description of variousembodiments and while these embodiments have been described inconsiderable detail, it is not the intention of the applicant torestrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. Thus, the invention in its broader aspects istherefore not limited to the specific details, representative apparatusand method, and illustrative example shown and described. Accordingly,departures may be made from such details without departing from thespirit or scope of applicants' general inventive concept.

What is claimed is:
 1. A method of operating a tissue treatmentapparatus to treat a region of tissue located beneath a skin surfacewith electromagnetic energy, the tissue treatment apparatus including ahandpiece that is handheld, a treatment tip from which theelectromagnetic energy is delivered, a carriage inside the handpiece andto which the treatment tip is attached, and a frame inside the handpieceand coupled with the carriage, the method comprising: delivering theelectromagnetic energy from the treatment tip through the skin surfaceto the region of tissue; and delivering the electromagnetic energy,moving the carriage and the treatment tip linearly relative to the frameas constrained by a connection between a first coupling element on theframe and a second coupling element on the carriage so as to transfermechanical vibrations through the skin surface and into the region oftissue by contact between a portion of the treatment tip and the skinsurface.
 2. The method of claim 1 wherein the mechanical vibrations aretransferred through the skin surface and into the region of tissue witha frequency between 20 Hz and 100 Hz.
 3. The method of claim 1 whereinmoving the treatment tip relative to the skin surface further comprises:operating a solenoid to move the carriage and the treatment tip in adirection primarily perpendicular to the skin surface.
 4. The method ofclaim 3 wherein the solenoid is configured to power movement of thetreatment tip at a power between 2 watts and 12 watts.
 5. The method ofclaim 3 wherein the solenoid is configured to move the treatment tip ata frequency between 20 Hz and 100 Hz.
 6. The method of claim 1 furthercomprising: dampening transfer of the mechanical vibrations to a portionof the tissue treatment apparatus that is handheld while transferringthe mechanical vibrations to the region of tissue.
 7. The method ofclaim 1 wherein the electromagnetic energy is delivered in a pulse overa time period, and transferring the mechanical vibrations comprises:increasing a vibration power or a vibration frequency of the mechanicalvibrations with increasing time during the time period.
 8. The method ofclaim 7 wherein the vibration power or the vibration frequency isincreased upwardly through a plurality of vibration levels havingincreasing vibration amplitude.
 9. The method of claim 8 wherein thevibration power or the vibration frequency is constant over an intervalcomprising each vibration level.
 10. The method of claim 7 wherein thevibration power or the vibration frequency is ramped upwardly at a givenrate over at least a portion of the time period.
 11. The method of claim7 wherein the mechanical vibrations are initiated subsequent to aninitiation of the pulse of the electromagnetic energy.
 12. The method ofclaim 1 wherein the mechanical vibrations are transferred through theskin surface and into the region of tissue after the delivery of theelectromagnetic energy is discontinued.
 13. The method of claim 1wherein the tissue treatment apparatus includes a vibration device thatgenerates the mechanical vibrations, a blower, and a housing in whichthe vibration device and the blower are located, and comprising:directing a forced air flow from the blower over the vibration device inorder to cool the vibration device.
 14. The method of claim 1 whereinthe electromagnetic energy is delivered in the radio-frequency band ofthe electromagnetic spectrum.
 15. A method of operating a tissuetreatment apparatus to treat a region of tissue located beneath a skinsurface with electromagnetic energy, the tissue treatment apparatusincluding a handpiece that is handheld, a treatment tip from which theelectromagnetic energy is delivered, and a carriage inside the handpieceand coupled with the treatment tip, the method comprising: deliveringthe electromagnetic energy from the treatment tip through the skinsurface to the region of tissue; contacting a cam surface on thecarriage with a profiled surface on a rotating cam element; andpermitting the carriage to bidirectionally pivot in opposite rotationalsenses about a pivot axis as the profiled surface on the cam elementrides in contact with the cam surface on the carriage to oscillate thecarriage and the treatment tip in a direction primarily transverse tothe skin surface so that mechanical vibrations are transferred throughthe skin surface and into the region of tissue by contact between aportion of the treatment tip and the skin surface.
 16. The method ofclaim 15 further comprising: dampening transfer of the mechanicalvibrations to a portion of the tissue treatment apparatus that ishandheld while transferring the mechanical vibrations to the region oftissue.
 17. A method of operating a tissue treatment apparatus to treata region of tissue located beneath a skin surface with electromagneticenergy, the tissue treatment apparatus including a handpiece with ahousing that is handheld, a treatment tip from which the electromagneticenergy is delivered, and a carriage inside the housing of the handpieceand coupled with the treatment tip, the method comprising: deliveringthe electromagnetic energy from the treatment tip through the skinsurface to the region of tissue; rotating an eccentric mass about anaxis of rotation as a counterweight effective to vibrate the carriageand the treatment tip in a direction transverse to a surface normal ofthe skin surface so that mechanical vibrations are transferred throughthe skin surface and into the region of tissue by contact between aportion of the treatment tip and the skin surface; and dampeningtransfer of the mechanical vibrations with vibration dampers suspendingthe carriage from the housing while transferring the mechanicalvibrations to the region of tissue.